We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01132495
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : December 9, 2016
Last Update Posted : February 2, 2017
Information provided by (Responsible Party):
St. Jude Medical

May 20, 2010
May 28, 2010
June 8, 2016
December 9, 2016
February 2, 2017
May 2010
January 2014   (Final data collection date for primary outcome measure)
Major Adverse Cardiac Event Rate (MACE) [ Time Frame: 24 Month ]
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
Same as current
Complete list of historical versions of study NCT01132495 on ClinicalTrials.gov Archive Site
Overall MACE [ Time Frame: 5 years ]
Non-urgent revascularization procedures, cost and cost effectiveness, functional class, number of anti-anginal medication, rate of non-urgent revascularization, and rate of cerebrovascular event.
Same as current
Not Provided
Not Provided
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease
The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.
Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Other: Stenting plus OMT
    FFR guided PCI, plus OMT
  • Other: OMT
    OMT alone
  • Other: Standard of care
    FFR > 0.80; treatment according to local practice
  • Cohort A: PCI plus OMT
    PCI plus optimal medical treatment
    Intervention: Other: Stenting plus OMT
  • Cohort A: OMT alone
    Optimal medical treatment alone
    Intervention: Other: OMT
  • Cohort B
    FFR > 0.80; treatment according to local practice
    Intervention: Other: Standard of care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2015
January 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with

    • stable angina or,
    • stabilized angina pectoris or,
    • atypical chest pain or no chest pain but with documented silent ischemia
  2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
  3. Eligible for PCI
  4. Signed written informed consent

Exclusion Criteria:

  1. Patients in whom the preferred treatment is CABG
  2. Patients with left main coronary artery disease requiring revascularization
  3. Patients with a recent STEMI or Non-STEMI
  4. Prior CABG
  5. Contra-indication to dual antiplatelet therapy
  6. LVEF < 30%
  7. Severe LV hypertrophy
  8. Planned need for concomitant cardiac surgery
  9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
  10. A life expectancy of less than 2 years
  11. Age under 21
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Ireland,   Italy,   Netherlands,   Serbia,   Sweden,   United Kingdom,   United States
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Bernard De Bruyne, MD O.L.Vrouwzlekenhuis Hospital
St. Jude Medical
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP